ALBUTEIN 200 G/L

Patient Information Leaflet: Instructions for the User

Albutein 200 g/l, solution for infusion
human albumin
Please read all of this leaflet carefully before this medicine is administered, because it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual only. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If any side effects occur in the patient, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Albutein 200 g/l is and what it is used for
2. Important information before using Albutein 200 g/l
3. How to use Albutein 200 g/l
4. Possible side effects
5. How to store Albutein 200 g/l
6. Contents of the pack and other information

1. What Albutein 200 g/l is and what it is used for

Albutein 200 g/l is a solution for intravenous infusion containing proteins derived from human plasma (plasma proteins), i.e. the liquid portion of human blood. Each vial/bottle/bag contains a plasma protein solution at a concentration of 200 g per litre, of which at least 95% is human albumin.
This medicinal product belongs to a group of medicines known as plasma substitutes and plasma protein fractions.
Albutein 200 g/l is used to restore and maintain circulating blood volume when volume deficiency has been demonstrated and when the use of a plasma substitute is indicated.
Albutein may be used in all age groups. For use in children, see section 4.
If you have any questions regarding the use of Albutein 200 g/l, please consult your doctor.

2. Important information before using Albutein 200 g/l

When not to use Albutein 200 g/l

• if the patient is allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Albutein 200 g/l, discuss this with your doctor, pharmacist, or
nurse.
Special caution is required when using Albutein 200 g/l:

• If the patient is at particular risk of increased blood volume, for example, has severe heart disease, high blood pressure, esophageal varices, pulmonary edema, coagulation disorders, severe red blood cell disorders, or anuria (lack of urine production).
• If symptoms of increased blood volume (headache, breathing difficulties, jugular vein distension) or increased blood pressure occur. Infusion must be stopped immediately.
• If symptoms of an allergic reaction occur. Infusion must be stopped immediately.
• If the medicine is administered to patients with severe traumatic brain injury.

For medicines manufactured from human blood or plasma, appropriate precautions are taken
to prevent transmission of infections to the patient. These include:

• careful selection of blood and plasma donors to exclude individuals who may be carriers of infections;
• testing of individual donations and pooled plasma for the presence of viruses/infections;
• inclusion of virus inactivation or removal steps during the processing of blood or plasma.

Nevertheless, it cannot be completely excluded that the use of medicines prepared from human
blood or plasma may transmit infection. This applies to all currently unknown or newly emerging
viruses and other types of infections.
No cases of viral infections transmitted by albumin products manufactured in accordance
with the requirements of the European Pharmacopoeia and using widely accepted processes
have been reported.
It is strongly recommended that, each time a patient receives a dose of Albutein 200 g/l,
the product name and batch number be recorded to maintain traceability of the batches used.

Children
The safety and efficacy of Albutein 200 g/l in children have not been established in controlled
clinical trials. However, clinical experience with the use of albumin in children suggests that
harmful effects are not expected, provided special attention is paid to dosing to avoid circulatory overload. See also section 4.

Albutein 200 g/l and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

No specific interactions between human albumin and other medicines are known.

Pregnancy, breastfeeding, and fertility

Pregnancy
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
The safety of Albutein 200 g/l in pregnant women has not been established in controlled
clinical trials. However, clinical experience with the use of albumin does not indicate harmful effects on pregnancy, the fetus, or the newborn.

Breastfeeding
It is not known whether Albutein 200 g/l passes into human milk. Passage of human albumin into milk has not been studied in animals. A decision should be made whether to continue/stop breastfeeding or to continue/stop treatment with Albutein 200 g/l, taking into account the benefits of breastfeeding for the child and the benefits of treatment with Albutein 200 g/l for the mother.

Effect on fertility
Studies on the effect of Albutein 200 g/l on reproduction in animals have not been conducted.
However, human albumin is a natural component of human blood.

Driving and operating machinery
No effects on the ability to drive or operate machinery have been observed.

Albutein 200 g/l contains sodium
The medicine contains 33.4 mg of sodium (main component of table salt) per 10 ml vial, 166.8 mg of sodium per 50 ml bottle/bag, and 333.5 mg of sodium per 100 ml bottle/bag. This corresponds to 1.7%, 8.3%, and 16.7% of the maximum recommended daily dietary sodium intake for adults, respectively.
The medicine contains potassium, less than 39 mg (1 mmol) per vial/bottle/bag, meaning the medicine is considered "potassium-free".

3. How to use Albutein 200 g/l

Albutein 200 g/l is intended for use in hospitals and will therefore be administered
in a hospital setting by qualified medical personnel.
The dose and infusion rate of Albutein 200 g/l, as well as the frequency and duration of treatment,
will be adjusted according to the individual patient's needs. These parameters
will be determined by the physician.
Administration of a higher than recommended dose of Albutein 200 g/l
If the patient believes that a higher than necessary dose of Albutein 200 g/l has been administered,
they should immediately inform the physician.
Missed dose of Albutein 200 g/l
Do not administer a double dose to make up for a missed dose.

4. Possible adverse reactions

Like any medicine, this medicinal product may cause adverse reactions, although not everybody will experience them.

• Mild reactions such as sudden reddening of the skin, skin rash, fever and nausea may occur rarely.
• Severe allergic reactions (anaphylactic shock) may occur very rarely.
• Information regarding the risk of viral infections, see section 2.

Additional adverse reactions in children
There are no detailed data available to determine the possible occurrence of various adverse reactions in this patient group.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to:
Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables continuous monitoring of the benefit-risk balance of the medicinal product.

5. How to store Albutein 200 g/l

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following: "Expiry date (EXP)".
Do not store above 30°C.
Do not freeze.
Store the vial/bottle/bag in the outer packaging to protect from light.
Do not use this medicine if the solution appears cloudy or if a precipitate is present.
After opening the packaging to prepare the infusion set, the contents should be used immediately.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Albutein 200 g/l contains

• The active substance is human albumin. One millilitre of Albutein 200 g/l contains 200 mg of plasma proteins, of which at least 95% is human albumin.
• Other ingredients are: sodium chloride, sodium caprylate, sodium N-acetyltryptophanate, and water for injections.

Manufactured from human plasma.
For additional information on the ingredients, see also “Albutein 200 g/l contains sodium” at the end of
section 2.
What Albutein 200 g/l looks like and contents of the pack
Albutein 200 g/l is an infusion solution. The solution is clear, slightly viscous, almost colourless, yellow,
amber, or green.
Albutein 200 g/l is available:

• In vials/bottles made of type II glass, with a chlorobutyl rubber stopper, aluminium seal, plastic cap, and a plastic shrink band ensuring tightness. The vial contains 10 ml of product, and the bottle contains 50 ml or 100 ml of product.
• In bags (FlexBag) made of polyethylene, in a protective packaging made of polypropylene. The bag contains 50 ml or 100 ml of product.

Pack sizes:

• 1 vial in a carton containing 10 ml
• 1 bottle in a carton containing 50 ml or 100 ml
• 1 bag in a carton containing 50 ml or 100 ml

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
INSTITUTO GRIFOLS, S.A.
c/Can Guasch, 2, Pol. Ind. Levante
Parets del Valles
08150 Barcelona, Spain
Marketing Authorisation Holder and Importer
INSTITUTO GRIFOLS, S.A.
c/Can Guasch, 2, Pol. Ind. Levante
Parets del Valles
08150 Barcelona, Spain
For more detailed information, please contact the representative of the Marketing Authorisation Holder.
Grifols Polska Sp. z o.o.
Ul. Siedmiogrodzka 9
01-204 Warsaw
Tel: +48 22 378 85 61
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Bulgaria, Croatia, Finland, France, Greece, Ireland, Iceland, Germany, Poland, Portugal,
Czech Republic, Romania, Slovakia, Sweden: Albutein 200 g/l
Denmark, Norway: Albumin Grifols 200 g/l
Italy: Albumina Umana Grifols 200 g/l
Spain: Albutein 200 g/l solución para perfusión
Detailed information on this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
Information intended for healthcare professionals only:

• The medicinal product Albutein 200 g/l can be administered directly intravenously. It may also be diluted in an isotonic solution (e.g. 5% glucose solution or 0.9% sodium chloride solution). Mixtures of electrolyte solutions should be prepared under aseptic conditions.
• Albumin solutions must not be diluted with water for injections, as this may cause haemolysis in patients receiving the solution.
• Do not mix human albumin with other medicinal products, whole blood, or red blood cell concentrates.
• Do not use cloudy solutions or those with sediment. This may indicate protein instability or contamination of the solution. After opening the container, its contents should be used immediately.
• Infusion should be administered intravenously using a sterile, single-use, non-pyrogenic infusion set. Before inserting the infusion set into the stopper, disinfect it with an appropriate antiseptic solution. After connecting the infusion set to the vial/bottle, the contents should be used immediately.
• The infusion rate should be adjusted according to the individual patient's condition and indication. During plasma exchange procedures, the infusion rate should be adjusted to match the rate of plasma removal. Hypervolaemia may occur if the dose and infusion rate are not adjusted to the patient's circulatory status. If early clinical signs of cardiovascular overload occur (headache, dyspnoea, jugular vein distension), or if arterial pressure increases, venous pressure rises, or pulmonary oedema develops, the infusion must be stopped immediately.
• If a large volume is to be administered, the medicinal product should be warmed to room temperature or body temperature before use.
• The 200 g/l albumin solution has a hyperoncotic effect. When administering concentrated albumin, ensure adequate hydration of the patient.
• Patients should be closely monitored to prevent circulatory overload and overhydration.
• During albumin administration, monitor the patient's electrolyte balance and take appropriate actions to maintain or restore it.
• Ensure adequate replacement of other blood components (clotting factors, electrolytes, platelets, and erythrocytes).
• Any unused portions of the product must be disposed of according to local regulations.

Bag:

• Do not remove the protective packaging until the product is ready for use. Moisture or condensation may be visible inside the protective packaging. This is normal and does not affect the quality or safety of the albumin solution.
• Before use, check the bag's integrity by firmly squeezing it. If leakage is detected, discard the solution.
• To connect the infusion set, break the seal by turning the valve.
• After connecting the infusion set to the bag, the contents should be used immediately.
• Do not use bags in series connections. Such use may cause an air embolism due to aspiration of residual air from the primary bag before completion of fluid administration from the secondary bag.